CTRP 3.9Planning Meeting

09.18.12

Agenda

• Review the Schedule for CTRP 3.9 (5 min)• Review Top Priorities and Major Work

Planned for CTRP 3.9 (50 min)• Review the Roadmap: Quick Look Ahead to

CTRP 3.10 (5 min)

9/18/12 2

SCHEDULE REVIEW

9/18/12 3

About the Dates

• The dates presented here seek to take into consideration:– Priorities for 3.9 based on the CTRP roadmap.– Size and LOEs of the proposed enhancements for 3.9.– Accommodating the NCI Systems blackout dates due to

the data center migration and the end of the year/holidays.

• The schedule has not yet been finalized or approved.

9/18/12 4

Proposed 3.9 Schedule(Timeline)

Development Starts

Feature Freeze/Release

Candidate 1QA

Sign OffSecurity Sign Off

3.15.13

3.9 Release Date 3/29/13

12.28.12 2.14.138.24.12

CTRO User Testing

User Guides Reviewed

Proposed Schedule – Not Finalized9/18/12 5

11 22 33 44 55 66 77 88 999 two week iterations

18 weeks (60%)Development

12 weeks (40%)QA, STAGE, Security

3.9m1 3.9m2 3.9m3 3.9rc1 …

The Development Phase9 two-week iterations planned

Iteration Dates Output of Iteration

1 - 3.9 Milestone 1 8/24 – 9/7 3.9M1

2 - 3.9 Milestone 2 9/10 – 9/21 3.9M2

3 - 3.9 Milestone 3 9/24 – 10/5 3.9M3

4 - 3.9 Milestone 4 10/8 – 10/19 3.9M4

5 - 3.9 Milestone 5 10/22 – 11/2 3.9M5

6 - 3.9 Milestone 6 11/5 – 11/16 3.9M6

7 - 3.9 Milestone 7 11/19 – 11/30 3.9M7

8 - 3.9 Milestone 8 12/3 – 12/14 3.9M8

9 – 3.9 Milestone 9 12/17 – 12/28 3.9 Release Candidate 1

9/18/12 6Proposed Schedule – Not Finalized

Schedule – List of Major MilestonesDevelopment 8/24 to 12/28 About 18 wks budgeted

Coding 8/24 to 12/28 Nine 2wk iterations

Feature Freeze 12/28 Team delivers 3.9 release candidate 1 to QA Team

QA 1/3 to 2/15 6 Weeks Total Budgeted

Testing of RCs by QA 1/3 – 1/25 Approx. 3 weeks budgeted

User Guides - drafts reviewed 1/8 – 2/14 Approx. 5 weeks budgeted

CTRO User Testing 1/10 – 1/17 Exact dates/env to be determined

Blocker/Critical Bugs Fixed 1/3 – 1/25 Team prepares add'l RCs as needed

Code Freeze 1/25 No code changes after this date

Regression Testing 1/28 – 2/8 Approx. 2 weeks budgeted

QA Acceptance 2/14 Approx. 1 week budgeted to get formal signoff

STAGE 2/15 to 3/15 4 weeks budgeted

Appscans on STAGE 2/15 – 3/15

Security Team Sign Off 3/15

PRODUCTION 3/18 to 3/29 2 weeks budgeted from Security Team Signoff

3.9 Deployed to PROD By 3/29/13

9/18/12 7Proposed Schedule – Not Finalized

SCOPE REVIEW

9/18/12 8

List of Top Priorities for 3.9(As previously agreed to based on prior planning sessions)

1. Adding support for Non-Interventional Trials (Sulekha)2. Automating nightly submission of NCI-Sponsored and Managed Trials from

CTRP to ClinicalTrials.gov (Farhan)3. Ability for internal NCI users to generate a complete and accurate Summary 4

Report (Charles)4. Additional enhancements to Biomarkers (Farhan)5. Additional enhancements to Accruals (Farhan)6. Expand Data Warehouse solution to include Accruals (Sulekha)7. PO Curation Tool Enhancements and Data Clean Up (Sulekha and Charles)8. Improvements to PA Inbox (Charles)9. Replace CTRO's reliance on Access-Based Tracking Sheet (Charles)10. Getting RSS to submit IRB documents via trial registration service (Farhan)11. Updated look and feel for Registry (Farhan)12. And … if time permits … other improvements to PA and Registry

9/18/12 9

1. Non-Interventional Trials• This is the #1 Ranked Priority for 3.9• Lead: Sulekha• Analysis is in progress. Should be ready for implementation soon.• Coding shedule to start in Iteration 3.

RegistryCTRP->Registry application should support registration of Non- interventional

trials.PA

CTRP->PA should support abstraction of Non-interventional trials.

9/18/12 10

Jira ID Description

PO-5453 Registry and PA: Non-interventional Trials

2. CTRP to ClinicalTrials.gov

• Automating nightly submission of NCI-Sponsored and Managed Trials from CTRP to ClinicalTrials.gov

• Lead: Farhan• Coding to start in Iteration 4

9/18/12 11

3. Summary 4 Report

• Lead: Charles• Analysis is in progress. • Dependent on Accruals and understanding

changes needed to how we manage organizations

• Coding to begin in Iteration 4

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4. Biomarkers• Lead: Farhan• Analysis is in Progress• Coding to begin in Iteration 2 or when ready• Table below lists potential items

9/25/12 13

Ranked List – from 9/19

5. Accruals• Lead: Farhan• Analysis is in Progress• Coding to begin in Iteration 2 or when ready• Table below lists potential items

14

Ranked List – from 9/20

9/25/12

6. Data Warehouse – Accrual Tables

PO-5445 Data Warehouse - Accrual - Please create DW_STUDY_SITE_ACCRUAL_ACCESS and populate the data

PO-5446 Data Warehouse - Accrual - Please create DW_STUDY_SITES_ACCRUAL_DETAILS and populate the data

PO-5447 Data Warehouse - Accrual - Please create DW_STUDY_ACCRUAL_COUNT and populate the data

PO-5448 Data Warehouse - Accrual - Please create DW_ACCRUAL_BATCH_SUBMISSION and populate the data

Lead: SulekhaKey Developer: HughAnalysis Complete.Coding in progress/scheduled for Iteration 2

9/18/12 15

7. PO CurationLead: Sulekha and CharlesAnalysis in Progress.Coding in progress/scheduled for Iteration 4

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PO-Curation (Cont'd)• PO Curation Enhancements:

PO Curation Scripts / Correction Module

Duplicate and Invalid CRs Auto Curation

Report Generation for Manual Review of Valid Organization CRs

CRs Report Review Response Processing

Organization Role Curation

Person Curation

179/18/12

PO-Curation(Cont'd)

PO Curation- Inbox Navigation Improvements

PO Curation - Enhancements to Curation Events Generation

PO Curation - CTEP Org Synch Process Evaluation

PO Curation - CTEP Person Synch Process Evaluation

189/18/12

PO-Curation (Cont'd)Jira ID Description

PO-5475 PO-Curation- Process CRs with same address as Current Organization Address

PO-5494 PO-Curation-Process CRs with same address as other CRs within same Organization

PO-5495 PO-Curation- Create a Report with Valid Organization CRs for Manual Review

PO-5496 PO-Curation-CRs Report Review Response Processing

PO-5497 PO-Curation-Organization Role Curation

199/18/12

8 & 9. PA Inbox Enhancements and CTRO Abstraction Tracking Process

• Lead: Charles• Analysis in Progress• Introduce “Abstractor Dashboard” for processing trials and

amendments:– My trials– Newly submitted trials– In-progress trials (Admin/Scientific Abstraction/QC)– Unreserved trials (Admin/Scientific Abstraction/QC)

• Manage site admin requests, including history• View site admin(s) and affiliated person(s) of an org• View trials owned, or submitted, by a person• View RSS daily run reports9/18/12 20

10. RSS to Submit IRB Documents to CTRP

• RSS team needs to update their system's code so it can use the existing CTRP trial registration service to submit IRB documents to CTRP.

• RSS team's timetable for this has slipped; they anticipate starting work on this in next couple of months.

• CTRP development team's role will be to provide support to RSS during testing.

• During testing, if it is determined that code changes to CTRP are needed, these will be included as part to 3.9.

9/18/12 21

11. Registry - UI Redesign

9/18/12 22

• Lead Analyst: Farhan • UI Engineer: Ben Trayhnam• Status: Early in Design Phase• Finalize Designs: By end of iteration 4, 10/19

• Goal: To give Registry a more fresh, modern look – and in this way make it easier, more pleasant to use.– Cleaner design– Web 2.0 features (like Google-type autocompleters) where appropriate– New CTRP logo?– We do not plan to make major changes to the workflow as part of the

UI redesign

Example: Mockup of Search Page

9/18/12 23

Example: Preliminary Mockup of Register Trial Page

Google like auto completer for Organization and Person fields.

9/18/12 24

Early Draft Mockups – Possible new logos for CTRP application

9/18/12 25

12. Some Additional Registration Enhancements(under consideration)

ID DescriptionPO-5424 Allow multiple organization selection for Summary 4 Funding Sponsor

PO-2846 Only applicable Orgs should be displayed in Registry Search

PO-2846 Remove ability for users to create new organizations in Registry

PO-5132 Association between submitting org and trial should not be tied to a person

PO-4801 A trial in CTRP should be able to have multiple Lead Organizations

PO-4877 Track users' annual reviews and updates to their trials

PO-4603 Allow sites to submit amendments for trials even while prior amendment is still being reviewed by CTRO

PO-4059 Trial Registration Service - enable updates and amendments using CTEP and other trial identifiers

PO-3875 Bring Registry UI in sync with the Service – add PurposeCodeAddtionalQualifier field to the UI

PO-2718 Expand Organizational Access feature in Registry so it can work across Organizations

It may not be possible to complete all of these in 3.9. Are any of these MUST HAVES?

9/18/12 26

Some additional PA Enhancements(under consideration)

ID DescriptionPO-5454 Make Arm Description field mandatory/part of validation in PA -- THIS IS DONE ALREADY.

PO-5422 Add "Other Pre-specified" Outcome Measure classification

PO-5479 Capture target enrollment on Industrial (abbreviated) trials

PO-3393 Highlight TSR and XML differences and add note about differences in email that system sends with TSR and XML

PO-3403 TSR: Consider flagging the data elements in the TSR which will be included in the ct.gov xml file

PO-4955 Add "contact backup" field to participating site fields to CTRP (This field exists in ClinicalTrials.gov) -- Request from FHCRC

PO-4954 Add "overall official" field to CTRP. (This field exists in ClinicalTrials.gov) – Request from FHCRC

PO-1961 Allow ctro to enter/select multiple keywords per trial

PO-4642 Capture a new data element for Complete trials i.e. when a PI at any given site is the author of the trial

PO-2430 Add new functionality for setting-up list of TSR senders

PO-3398 Eligibility Criteria: add cut and paste function for an eligibility criteria

9/18/12 27

It may not be possible to complete all of these in 3.9. Are any of these MUST HAVES?

Dates for Freezing RequirementsItem Lead

AnalystAnalysis Should Be Finalized By

Development to Occur In Following Iterations

1. Non-Interventional Trials Sulekha End of Iteration 2 (9/21) 3, 4

2. Automated nightly update between CTRP and CT.gov for NCI-Sponsored Trials

Farhan End of Iteration 3 (10/5) 4, 5, 6

3. Ability for internal NCI users to generate a complete and accurate Summary 4 Report.

Charles End of Iteration 4 (10/19) 5, 6, 7, 8, 9

4. Biomarker Enhancements Farhan End of Iteration 2 (9/21) 3, 4

5. Accrual Enhancements Farhan End of Iteration 2 (9/21) 3, 4, 5

6. Add Accruals to DW solution Sulekha End of Iteration 1 (9/7) 2

7. PO Curation Sulekha and Charles

End of Iteration 4 (10/19) 4, 5, 6, 7, 8

8&9. Improvements to PA Inbox and Search to better match CTRO's workflow and process

Charles End of Iteration 2 (9/21) 3, 4, 5

10. RSS submit IRB documents to CTRP via service Farhan End of Iteration 4 (10/19) --

11. Updated look and feel for Registry Farhan End of Iteration 4 (10/19) 5, 6

Bug Fixes -- N/A 1, 2, 3, 4, 5, 6, 7, 8, 9

Production Support N/A N/A 1, 2, 3, 4, 5, 6, 7, 8, 9

9/18/12 28

ROADMAP REVIEW

9/18/12 29

A Look Ahead3.8.1 (Fall 2012) 3.9 (Spring 2013) 3.10 (Fall 2013)

Accruals – Major Improvements to processing logic and performance Non-interventional Trials CTRP/NLM: Nightly Synch to CTRP from

ClinicalTrials.gov & other trials (Path #11)

Assorted PA Improvements PO Reorg Enable reporting for cancer community

Assorted Registry Improvements Summary 4 – Internal NCI users NCi Thesaurus. Change source of termiology from PDQ to NCI Thesaurus. (Path #20)

Accrual Enhancements Integrate with Grants System (PO-2033) (Path #22)

PO Curation Tool Enhancements Integrate with IRB System (OHRP) (PO-2041) (Path #23)

Automated update of NCI Sponsored trials in PRS from CTRP (Path #12)

Integrate with CTEP ESYS to obtain full protocol data set. (Path #7)

)

PA Inbox enhancements Audit Trail history screens

Replace CTRO's reliance on Access Based Tracking Sheet

Assorted Biomarker enhancements

DW to include Accruals data

New UI for Registry

IRB document submissions from RSS (Path #3)

9/18/12 30

9/18/12 31

Systems Integration Slide for Reference – Before 3.9

441414

1818

1313

1010

88

1616

1212

9/18/12 32

Systems Integration Slide for Reference – After 3.9

441414

1818

1313

1010

88

1616

1212

33

66

1212

AFTER 3.9 – THESE ARE THE HIGH-LEVEL ITEMS FROM ROADMAP THAT WILL BE COMPLETED#

• Path 1: Responsible Party or Cancer Center sends New Trial or Amendment to CTEP/DCP PIO• Path 2: Participating Sites send updates to CTSU RSS• Path 3: CTSU RSS provides Trial IRB data to CTRP using CTRP Trial Registration Service• Path 4: CTSU RSS sends participating site information/updates to CTRP using CTRP Participating Site service• Path 5: CTEP/DCP PIO sends New Trial and Amendments to CTRP (via email)Path 7: CTRP to get protocol

abstraction data from CTEP ESYS for CTEP/DCP Trials• Path 6: CTRP and ECM share/exchange Person and Organization data*• Path 8: CDUS data can be uploaded into CTRP using the CTRP service, batch mechanism, or web UI• Path 10: CTRP provides nightly dump of Protocol XML files for import by Cancer.gov (PDQ)• Path 12: Automate the nightly update of NCI Sponsored trials in ClinicalTrials.gov with XML from CTRP• Path 13: PRS uploads trial XML from CTRP• Path 14: Responsible Party or Cancer Center registers trial in CTRP via Trial Registration Service• Path 15: CTRP provides Responsible Party or Center with TSR and XML. XML conforms to ClinicalTrials.gov

submission requirements• Path 16: Participating Sites are able to add their sites to Industry trials in CTRP**• Path 17: Cancer Centers using Velos are able to submit trial registrations to CTRP via service**• Path 18: Cancer Centers using OnCore are able to submit trial registrations to CTRP via service• Path 19: Responsible Party or Cancer Center submits new trial, update, or amendment to CTRP via UI or Batch-----------------------------------

# = Operational and (from perspective of baseline requirements) completed -- but need for additional improvements or changes may still arise* = Operational, but further integration with CTEP ECM System is envisioned** = CTRP supports but vendors may not be fully integrated with or utilizing CTRP services yet9/18/12 33

AFTER 3.9 – THESE ARE ITEMS FROM FROM ROADMAP THAT WILL STILL REMAIN

System Integrations:• Path 7: CTRP to get protocol abstraction data from CTEP ESYS for CTEP/DCP Trials• Path 9: 3rd party CTMS systems can query CTRP for Protocol data • Path 11: ClinicalTrials.gov provides nightly synch and other trials to CTRP • Path 20: CTRP obtains terminology from EVS NCI Thesaurus • Path 21: CTRP integrated with Firebird for exchange of credentialing data • Path 22: CTRP Integrated with Grants system (IMPACTII)• Path 23: CTRP Integrated with IRB system (OHRP)

Other:• Implement full Auditing Framework and View History feature in PA• BRIDG Harmonization• Assorted Feature Requests, Enhancements, and Improvements• Bug Fixes• Tech Debt Backlog 9/18/12 34

END

9/18/12 35

EXTRA SLIDES

9/18/12 36